USA – FDA Releases Handful of Recent Form 483s

The US Food and Drug Administration (FDA) on Monday released five Form 483s sent to manufacturers in India, Japan and the US either because they had been frequently requested or because FDA wanted to proactively post the reports.

Cook Pharmica

Bloomington, Indiana-based Cook Pharmica received this Form 483 on 1 May, following a seven-day inspection in late April. The redacted Form 483 includes five observations, including one for “an unacceptably high number of mold recoveries in the classified rooms” used to manufacture a bulk substance. The company was also cited for a lack of quality oversight in the review of records and procedures following the manufacture of drug substance.

Sun Pharmaceutical Industries 

This Form 483 issued on 31 August follows a five-day inspection at the company’s Halol, India-based site and includes six observations. Among the observations, FDA said it “observed unused stability samples stored inside a Styrofoam cooler, on top of a stool.” The firm was also cited for failing to have procedures designed to prevent objectionable microorganisms in drug products.

Yuki Gosei Kogyo

Nine observations were cited in this Form 483 for the company’s Fukushima, Japan-based active pharmaceutical ingredient (API) manufacturing site. Among the observations is a deficiency associated with supervisory oversight of the lab electronic systems and data…