# FDA EIR - Johnson & Johnson Consumer Inc - March 11, 2020

Source: https://www.keypedia.com/records/eir/johnson-johnson-consumer-inc/894de33b-ec70-4292-bcb4-2c5c93948fbd

> FDA EIR for Johnson & Johnson Consumer Inc on March 11, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Johnson & Johnson Consumer Inc
- Inspection Date: 2020-03-11
- Product Type: Drugs
- Office Name: Office of Pharmaceutical Quality Operations Division I
- Summary: An unannounced routine surveillance inspection of Johnson & Johnson Consumer Inc, located in Los Angeles, CA, was conducted by the Food and Drug Administration from March 9 to March 11, 2020. The inspection aimed to assess the firm's compliance with current Good Manufacturing Practices (cGMP) for its manufacturing of Over-the-Counter (OTC) drugs and cosmetic products, including items such as acne soap, facial creams, and sunscreens. This assessment was carried out under Compliance Program 7356.002, focusing on drug process systems including quality, materials, production, and laboratory. A primary objective was to verify the adequacy of corrective actions taken following a previous inspection in October 2015, which identified issues with drug product storage temperatures. The FDA confirmed these prior corrections were satisfactory. Notably, the current inspection identified no major objectionable conditions, and consequently, no Inspectional Observations (FDA-483) were issued. The inspection concluded with a "No Action Indicated" classification, signifying full compliance, and a routine reinspection was recommended.

## Related Documents

- [483 - 2010-08-12](https://www.keypedia.com/records/483/johnson-johnson-consumer-inc/1ad5f0ba-04db-4153-9c1d-1e2d2fedec02)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/richmond-k-yip/7af5271a-4902-4651-a899-61bf8f826cf7)
- [Investigator](https://www.keypedia.com/people/truong-x-nguyen/8f3aed17-0507-4272-a3b8-9188d761faed)
- [company_representative](https://www.keypedia.com/people/curt-syring/936ed2f1-7439-4075-b564-12152e19a50b)

Company: https://www.keypedia.com/companies/johnson-johnson-consumer-inc/8f348929-c130-43c6-9115-3a609fb0d9d6

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-quality-operations-division-i/798d6a62-d1f1-4f7c-8de3-465e277c13da