Enforcement:
- Recalls:
- Some Class II and III recalls
- The effects of the valsartan API problems continue — see the 2 News Scan Top Stories.
- Import Alerts:
- A few import alerts including 1 valsartan site. I would look for a warning letter for this site soon. This same site also received a report of GMP non-compliance from the EDQM and EMA.
- Warning Letters:
- Drug Manufacturers: 6 warning letters
- The FDA continues to focus on OTC manufacturers in the drug area.
- Compounding Pharmacies: 4 warning letters
- Device Firms: 3 warning letters
- FDA also issued 1,300 warning letters from the Center for Tobacco Products regarding flavored electronic cigarettes. I would expect to see additional action against this product type in the future.
- Drug Manufacturers: 6 warning letters
- 483s:
- We provide 5 483s that FDA recently made available.
- One of the 483s that FDA posted went to Zhejiang Huahai Pharmaceutical Co., a company in China that manufactured the API for valsartan products containing a carcinogenic impurity.
- Untitled Letters: 1 to a compounding pharmacy.
- The Europeans Published:
- 2 reports of GDP non-compliance for 2 firms in Romania.
- 1 report of GMP non-compliance addressing the refusal of a firm in China to permit an inspection.
Laws & Guidance:
- Guidance | The US, EMA, Health Canada, CDSCO, and ICH published:
- 4+ publications addressing devices
- 2 guidance focusing on quality:
- The most relevant may be the draft guidance on post approval changes to drug substance. Because this addresses APIs supported by DMF filings, it would be interesting to consider whether any of these new requirements MAY have served to identify the current impurity in the Valsartan drug substance. Just a thought, the timing here is curious.
- 3 guidance addressing concepts in the DSCS Act regarding product identifiers.
- Some guidance addressing compounding pharmacies and generic drugs.
- TGA also published 1 guidance regarding mandatory reporting for drug shortages starting in 2019.
- The EMA, MHRA, HPRA, and FDA all published non-guidance.