# FDA EIR - BASF SE - July 13, 2018

Source: https://www.keypedia.com/records/eir/basf-se/27087d27-999a-4777-9750-163ec739a1a1

> FDA EIR for BASF SE on July 13, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: BASF SE
- Inspection Date: 2018-07-13
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: A routine FDA surveillance inspection of BASF SE, located in Ludwigshafen Am Rhein, Germany, was conducted from July 9 to July 13, 2018. The inspection focused on good manufacturing practices (GMP) for non-sterile active pharmaceutical ingredients (API), guided by Compliance Program 7356.002F and ICH Q7 guidance. This review covered six key systems, including quality, facilities, materials, production, packaging, and laboratory controls.

The inspection concluded with the issuance of a three-item FDA Form 483, detailing observations of deficiencies. Key issues included the inadequacy of System Suitability for Test Method #PM00760, which lacked a precision Standard System Suitability (% RSD). Additionally, procedures for instrument calibration were found to be deficiently written or followed. Finally, the company lacked established control procedures to validate manufacturing processes that could impact variability in the packaging process.

Dr. Rainer Fendt, Global Quality Compliance Director, acknowledged these observations and committed to implementing corrective actions. BASF SE is required to submit a comprehensive response addressing these findings to the agency within 15 business days. The firm's drug manufacturer registration remains current.

## Related Documents

- [EIR - 2010-03-17](https://www.keypedia.com/records/eir/basf-se/c5f29c33-7620-43c4-8738-516f12311f28)
- [EIR - 2013-07-30](https://www.keypedia.com/records/eir/basf-se/57e1a517-1e11-4748-9af8-82b93854b791)
- [EIR - 2016-03-10](https://www.keypedia.com/records/eir/basf-se/7a679d34-3064-422a-a80d-92783d966800)
- [EIR - 2018-07-13](https://www.keypedia.com/records/eir/basf-se/7dd33db3-3652-4440-894b-b6cd6f7d530c)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/valerie-l-whipp/70c97f44-c351-499b-afd3-166b4330ae52)
- [Chemist at US Department of Health and Human Services](https://www.keypedia.com/people/felix-maldonado/d7a5c4bd-2aa7-405f-b3c4-17ef35152ab4)

Company: https://www.keypedia.com/companies/basf-se/96b65069-a37b-4a26-9655-5f310b60cc6f

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64