# Pharmaplast S.A.E. – FDA 483, Feb 6, 2025

Source: https://www.keypedia.com/records/483/pharmaplast-sae/e063d48b-988d-4fb2-9a56-a5a441f37707

> FDA 483 for Pharmaplast S.A.E. on February 06, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaplast S.A.E.
- Inspection Date: 2025-02-06
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Pharmaplast S.A.E., an OTC drug manufacturer in Alexandria, Egypt, was cited for significant deficiencies across its laboratory controls, quality unit operations, computerized systems, and record-keeping during an FDA inspection. The observations highlight a systemic lack of data integrity, inadequate testing procedures, ineffective quality oversight, and insufficient control over critical manufacturing processes and documentation. These issues indicate a serious failure to ensure the safety, efficacy, purity, and overall quality of drug products distributed to the US market.

## Related Documents

- [483 - 2022-11-10](https://www.keypedia.com/records/483/pharmaplast-sae/62e339cf-83f5-4fb2-ab22-374049557d33) — date: November 10, 2022
- [WARNING_LETTER - 2022-11-10](https://www.keypedia.com/records/warning_letter/pharmaplast-sae/57f077eb-306b-4791-a20d-299a21bfa0ab) — date: November 10, 2022

## Related Officers

- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.keypedia.com/companies/pharmaplast-sae/69fdda1e-d63c-4bd4-b5ed-402c137267a5

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8