# Petra Hygienic Systems Int Ltd – FDA Inspection, Dec 21, 2018

Source: https://www.keypedia.com/records/fda_inspections/petra-hygienic-systems-int-ltd/2c54d3b9-50af-4419-8ffd-720f6fca31e2
Source feed: FDA_Inspections

> FDA inspection 1075197 of Petra Hygienic Systems Int Ltd, December 21, 2018. Classification: Official Action Indicated (OAI). 5 citations under 21 CFR part 211. Form 483 issued. 3 other FDA inspections on record for this company.

---

## Details

- Record Type: FDA Inspection
- Inspection ID: 1075197
- Company Name: Petra Hygienic Systems Int Ltd
- Inspection Date: 2018-12-21
- Classification: Official Action Indicated (OAI)
- Classification Code: OAI
- Project Area: Drug Quality Assurance
- Product Type: Drugs
- Center: Human Drugs
- Office Name: Center for Drug Evaluation and Research
- Citation Count: 5
- Enforcement Type: WARNING_LETTER

## Related Documents

- [FDA Inspection 1168565 - 2022-04-22](https://www.keypedia.com/records/fda_inspections/petra-hygienic-systems-int-ltd/20274aca-ddbe-44fa-a2fd-3ace1c2f6d4b)
- [FDA Inspection 911653 - 2014-12-12](https://www.keypedia.com/records/fda_inspections/petra-hygienic-systems-int-ltd/72b5d814-8905-4893-942b-7971a81f2e34)
- FDA Inspection 770125 - 2012-02-09

## Related Officers

- [Issuing Officer](https://www.keypedia.com/people/william-j-leonard/b2e10570-6c89-4f62-a0aa-baeea6373512)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c