Week of May 19th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

This week’s postings included two to drug manufacturers and three to device manufacturers. FDA’s website update makes warning letters a bit more difficult to monitor because they no longer list the date the letter is posted on the website. The letters continue to be listed, however, in chronological order, so if an older letter is posted it’s going to be easy to miss. Here is this week’s collection.

DRUG | Centurion Laboratories Private Limited

Centurion Laboratories Private Limited (Gujarat, India) received a warning letter on April 5, 2019 based on the outcome of an inspection ending October 26, 2018. The firm was placed on Import Alert 66-40 on March 11, 2019.

FDA also recommends the firm hire a qualified consultant to assist them in coming into GMP compliance. The warning letter cites two deficiencies in the area of data integrity and one regarding cleaning and maintenance of equipment.

Deficiencies include but are not limited to:

• Investigators found torn documents of stability data, analytical testing sheets, calculations and release forms in trash bags. Blank stability study forms were pre-signed and approved by the Quality unit prior to data collection.
• The firm did not have adequate controls over computer systems. QC analysts, a company executive and software service provider all shared a username and password for HPLC systems.
• Multi-product equipment was visibly dirty. According to a memo provided during the inspection, inadequate cleaning and maintenance of equipment was due to a “…shortage of manpower related to a nine-day dancing festival and government holiday.”

DRUG | AMMD Labs, LLC

AMMD Labs, LLC (Pompano Beach, FL) received a warning letter on May 2, 2019 based on the outcome of an inspection ending September 14, 2018. The firm manufactures OTC products and sunscreen.

The firm failed to respond to the FDA form 483 within 15 days, though they did respond eventually. FDA suggests the firm hire qualified consultant(s) to assist them in coming into GMP compliance. The firm was also cited for misbranding and distribution of unapproved new drugs.

Deficiencies include but are not limited to:

• The firm did not test product released to market to ensure they met specifications and identity.
• The firm failed to validate their manufacturing processes. The water system is not adequately designed, was not validated and contains dead legs.
• Data are not available to support the 3-year expiry dating.
• The Quality Unit did not fulfill its responsibilities and includes a long list of failures along with instruction for management to provide appropriate authority and sufficient resources for the Q-unit. Further, “Because your QU failed to fulfill its role, you lacked assurance that appropriate manufacturing and quality standards are met for each of your drug products.”

DEVICE | Rechargeable Power Energy North America, LLC

Rechargeable Power Energy North America, LLC (Las Vegas, NV) received a warning letter on May 9, 2019 based on the outcome of an inspection ending November 9, 2018. The firm manufactures automated external defibrillator replacement batteries.

Deficiencies include but are not limited to:

• The firm could not demonstrate that the process for finished product functional testing was validated. This is a repeat observation from an inspection of January 2016.
• The firm has not established a process for managing complaints. Again, a repeat observation from January 2016.
• Device history records have not been established to ensure and demonstrate that devices are manufactured consistently with the device master record.
• The firm has no process for supplier review and approval. Yet another repeat observation from January 2016.
• The firm does not have a process and procedures to ensure incoming products are inspected, testing or verified to comply with specific requirements. “This observation was verbally discussed during the closeout meeting on 11/9/2018 and not included on the Form FDA 483. However, after further review by the Agency and the information provided during the inspection, it was determined that this observation is significant and noted on the Warning Letter to ensure compliance with the requirements of 21 CFR 820.80(b).”
• The firm lacks a CAPA process. Another repeat from January 2016.
• The firm does not have a process for internal audits. One more from the inspection in 2016.
• The firm does not have procedures for conducting and documenting management review. Yet again, a repeat from 2016.
• The firm was also cited form misbranding; they failed to have MDR procedures for reporting to FDA and, last but not least, they failed to register with FDA that they are a [contract] manufacturer.  

DEVICE | Zeller Power Products, LLC

Zeller Power Products, LLC (Wallace, ID) received a warning letter on May 9, 2019 based on the outcome of an inspection ending November 9, 2018. This firm also manufactures replacement batteries for automated external defibrillators.

Deficiencies include but are not limited to:

• The firm could not provide documentation to demonstrate design validation for the shelf-life of five years from date of manufacture. Software installed on the printed circuit boards included in each battery has not been validated. “In response to this Warning Letter, you should provide your plans to ensure that the Zeller AED battery has been designed and validated based on the requirements set forth in QSR Part 820.” This is a repeat observation from a January 2016 inspection.
• The firm does not have design control procedures. Again, a repeat from January 2016.
• A process for management of complaints has not been developed and implemented. There is no process or procedure for MDR reporting.  Another January 2016 repeat.
• The firm does not have processes or procedures to verify finished devices provided by your contract manufacturer.
• There is no process for managing non-conforming materials. “This observation was verbally discussed during the closeout meeting on 11/9/2018 and not included on the Form FDA 483. However, it was determined after further review by the Agency and the information provided during the inspection, that this observation is significant and is noted on the Warning Letter to ensure compliance with the requirements of 21 CFR 820.90(a).”
• The firm has not established CAPA processes and procedures. Yet another from January 2016.
• The FDA also identifies deficiencies in labeling. The firm is also a ‘labeler”.
• The firm did not provide information to the Global Unique Device Identification Database.
• “The Center for Devices and Radiological Health (CDRH) stated a final order was issued on February 3, 2015 calling for a premarket approval (PMA) for this device. The AED Final Order calls for a PMA to be submitted for AED batteries. Zeller Power Products can continue to market and distribute your device without a PMA until February 3, 2020.”
• And last but not least, the firm is deficient in adhering to medical device registration and listing requirements.

DEVICE | Orchid Orthopedic Solutions, LLC

Orchid Orthopedic Solutions, LLC (Holt, MI) received a warning letter on May 13, 2019 based on the outcome of an inspection ending February 15, 2019. The firm applies coatings to orthopedic implants that promote bone ingrowth.

Deficiencies include but are not limited to:

• Failure to require documentation of reworks of product.
• Failure to have an adequately monitored water system. Water is used in the device cleaning process.
• The CAPA process does not address how changes to CAPA plans are managed, nor does it provide for means to handle supplier corrective action requests.
• The manual cleaning process for implants has not been adequately validated.
• Procedures for receiving, reviewing and evaluating complaints by a formally designated unit have not been established.
• The internal audit program is inadequate.