# FDA 483 - AstraZeneca Pharmaceuticals LP - June 07, 2024

Source: https://www.keypedia.com/records/483/astrazeneca-pharmaceuticals-lp/aea2bb99-1045-4587-8aea-e4bb1a016450

> FDA 483 for AstraZeneca Pharmaceuticals LP on June 07, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: AstraZeneca Pharmaceuticals LP
- Inspection Date: 2024-06-07
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: An FDA inspection conducted from May 30 to June 7, 2024, at AstraZeneca Pharmaceuticals LP Frederick Manufacturing Center, a drug substance manufacturer, identified four significant observations detailed in a Form FDA 483. The inspection highlighted critical deficiencies in quality and manufacturing controls. A primary concern was unmitigated risks in upstream manufacturing systems, evidenced by 23 contamination events across two buildings between 2020 and 2024. This was noted as a repeat observation, indicating a persistent failure to address system deficiencies. Further issues included deficient manufacturing and quality control laboratory procedures. These encompassed a lack of governance for cleaning validation failures, leading to subsequent production on inadequately validated equipment. Inspectors also found residual material in a "clean" raw material dispense area, dislodged HEPA screens, unsealed wall interfaces, deteriorated sealants, and uncleaned cabinet surfaces, all indicating poor facility control and deficient cleaning procedures. Additionally, numerous Quality Control lab temperature units were found in alarm conditions without a routine inspection procedure. The inspection also noted a failure to thoroughly document the product quality impact of quality events, with deviation reports lacking clear evaluation for "no product impact" conclusions. Lastly, analytical instruments used for manufacturing in-process controls, despite having audit trails, were not routinely reviewed, posing a data integrity risk. AstraZeneca is required to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with manufacturing standards.

## Related Documents

- [483 - 2021-03-19](https://www.keypedia.com/records/483/astrazeneca-pharmaceuticals-lp/b308dbbf-6bee-4596-8859-b6320002a2e9)
- [EIR - 2021-03-19](https://www.keypedia.com/records/eir/astrazeneca-pharmaceuticals-lp/a9e01aea-4641-46b2-9417-2ecc9c9d80aa)
- [483 - 2023-01-19](https://www.keypedia.com/records/483/astrazeneca-pharmaceuticals-lp/05295a30-e31b-4220-a8bf-8906643f78cd)
- [WARNING_LETTER - 2023-08-15](https://www.keypedia.com/records/warning_letter/astrazeneca-pharmaceuticals-lp/ffb41aa4-e9b4-4e4e-b72f-9cf78acb857c)
- [483 - 2024-06-07](https://www.keypedia.com/records/483/astrazeneca-pharmaceuticals-lp/6809d725-a3ed-4b2b-b0a2-b81cc7e01672)

## Related Officers

- [recipient](https://www.keypedia.com/people/wayne-farnsworth/95fc267d-e1f1-43f3-a9ce-c584e93822c5)
- [other](https://www.keypedia.com/people/lee-pai-scherf/c6ee2b74-fcf8-4c80-878d-fe3bb6c2c7ed)
- [Liqun Zhao](https://www.keypedia.com/people/liqun-zhao/6fdfb753-7788-4351-9b0b-65e06c201bc5)
- [Kristen Nickens](https://www.keypedia.com/people/kristen-nickens/d68c87e1-e14c-48f7-86e9-686a3870c777)
- [Wayne E. Seifert, Consumer Safety Officer](https://www.keypedia.com/people/wayne-e-seifert-consumer-safety-officer/cac154a9-1840-4a78-a677-67ec0df0337f)

Company: https://www.keypedia.com/companies/astrazeneca-pharmaceuticals-lp/6f9abb75-9352-43df-b761-026089396fa3

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa