# FDA 483 - Petra Hygienic Systems Int Ltd - April 22, 2022

Source: https://www.keypedia.com/records/483/petra-hygienic-systems-int-ltd/d121efda-c719-4646-a203-a916eaedbef2

> FDA 483 for Petra Hygienic Systems Int Ltd on April 22, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Petra Hygienic Systems Int Ltd
- Inspection Date: 2022-04-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Petra Hygienic Systems Int Ltd, an OTC drug manufacturer in Concord, revealed significant and repeated deficiencies in their manufacturing processes. The firm lacked adequate written procedures for production, quality control, equipment cleaning, and stability testing. Furthermore, issues with microbial testing, data integrity in computer systems, and raw material identity verification were noted, with several problems being repeats from a previous inspection.

## Related Documents

- [WARNING_LETTER - 2018-12-21](https://www.keypedia.com/records/warning_letter/petra-hygienic-systems-int-ltd/0a373a4d-ed90-40db-b08e-4a69515936cb)

## Related Officers

- [Scott N. Lim](https://www.keypedia.com/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)

Company: https://www.keypedia.com/companies/petra-hygienic-systems-int-ltd/0413dd25-8e8f-4a44-8316-0ded90ea4aac

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1