# FDA 483 - ENDO USA, Inc. - August 31, 2010

Source: https://www.keypedia.com/records/483/endo-usa-inc/d670c0c9-7a93-4508-a39b-e5bdb8059c15

> FDA 483 for ENDO USA, Inc. on August 31, 2010. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ENDO USA, Inc.
- Inspection Date: 2010-08-31
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of JHP Pharmaceuticals, LLC in Rochester, MI, revealed significant deficiencies in equipment cleaning, design, and quality control procedures. Inspectors found drug product residues on HEPA filters and supply air outlets due to inadequate cleaning intervals and equipment design flaws. The quality control unit also lacked proper written procedures for handling product spills and managing room hold statuses, indicating a breakdown in GMP compliance.

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## Related Officers

- [Associate Director](https://www.keypedia.com/people/jeffrey-d-meng/55543677-bd74-4cc5-8a2a-e14afb91d338)
- [Michele L. Forster](https://www.keypedia.com/people/michele-l-forster/5e4b6db7-412f-4e4f-87a9-8af15a16429f)

Company: https://www.keypedia.com/companies/endo-usa-inc/f2df2e47-8303-4a2c-9881-5e2ecef64f22

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0