# FDA 483 - BOEHRINGER INGELHEIM PROMECO S.A. de C.V. - May 20, 2022

Source: https://www.keypedia.com/records/483/boehringer-ingelheim-promeco-sa-de-cv/52e1f5b4-75f5-401b-81cd-27e099cb3453

> FDA 483 for BOEHRINGER INGELHEIM PROMECO S.A. de C.V. on May 20, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BOEHRINGER INGELHEIM PROMECO S.A. de C.V.
- Inspection Date: 2022-05-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: This FDA Form 483 was issued to BOEHRINGER INGELHEIM PROMECO S.A. de C.V., a drug manufacturer in Ciudad De Mexico, following an inspection. Observations included deficiencies in equipment design for cleaning and maintenance, lack of testing procedures for raw materials used in drug production, and inadequate quality control unit responsibilities regarding procedure approvals and OOS investigations. The findings indicate issues with manufacturing controls and quality system oversight.

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## Related Officers

- [Investigator ](https://www.keypedia.com/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)
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Company: https://www.keypedia.com/companies/boehringer-ingelheim-promeco-sa-de-cv/d1f077c2-d2d3-4a71-b897-7595adbb343b

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1