# FDA 483 - Pfizer Ireland Pharmaceuticals Unlimited Company - September 10, 2018

Source: https://www.keypedia.com/records/483/pfizer-ireland-pharmaceuticals-unlimited-company/f2438b2c-36b8-4595-85a2-d5958774a57b

> FDA 483 for Pfizer Ireland Pharmaceuticals Unlimited Company on September 10, 2018. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Pfizer Ireland Pharmaceuticals Unlimited Company
- Inspection Date: 2018-09-10
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Pfizer Ireland Pharmaceuticals, a drug manufacturer in Clondalkin, Ireland, received a Form 483 citing several significant deficiencies during an FDA inspection. Observations included inadequate investigation records for unexplained discrepancies, insufficient review of atypical test results, ambiguous adverse event reporting, and deficiencies in environmental monitoring and laboratory controls. These issues indicate a need for improved quality system oversight and adherence to GMP requirements.

## Related Documents

- [EIR - 2019-11-12](https://www.keypedia.com/records/eir/pfizer-ireland-pharmaceuticals-unlimited-company/5c396add-76b1-43b1-84e2-efc576a801e8)
- [483 - 2019-11-12](https://www.keypedia.com/records/483/pfizer-ireland-pharmaceuticals-unlimited-company/67e84118-13d5-491c-b980-4f7516269ab2)
- [483 - 2023-05-11](https://www.keypedia.com/records/483/pfizer-ireland-pharmaceuticals-unlimited-company/aa02473c-1999-4603-ab70-50607957c9d0)

## Related Officers

- [CSO](https://www.keypedia.com/people/mihaly-s-ligmond/2904ef70-a757-49c7-9ac4-a2c07ee36001)
- [issuing_officer](https://www.keypedia.com/people/scott-e-norris/8093919d-6e81-4629-8715-5e78be5c953a)

Company: https://www.keypedia.com/companies/pfizer-ireland-pharmaceuticals-unlimited-company/095513de-fb4d-4c57-847c-bef3a3b235f4

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd