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Regulatory Focus™ > News Articles > 9 > FDA Releases Handful of Recent Form 483s

FDA Releases Handful of Recent Form 483s

Posted 10 September 2018 | By Zachary Brennan 

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.

Unichem Laboratories

The Dhar, India-based manufacturer received this Form 483 on 27 July following a four-day inspection. Four observations were recorded, including that the firms cleaning procedures are not validated and that test procedures are not scientifically sound and appropriate to ensure raw materials, APIs, intermediates, labeling and packaging materials conform to established standards of quality and/or purity.

Liva Pharmaceuticals

Waghodia, India-based Liva received its Form 483 on 28 August following eight days of inspections. Five observations were recorded, including the firm’s failure to follow established and approved standard operating procedures.

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