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Procter & Gamble Manufacturing Mexico, S. de R.L. de C.V.
FDA establishment 3002744909, Naucalpan, Mexico. Part of Procter & Gamble Manufactura's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
Inspections: 3
Official action indicated: 0
Last inspection ended: Jun 27, 2025
Warning letters: 2
Import refusals since 2024: 17
Import refusals 2014 to 2023: 10, first Dec 1, 2014
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.188(b)(11). Identification of Persons Performing Significant Steps The batch production and control records are deficient in that they do not include identification of persons supervising each significant step in the operation.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Voluntary Action Indicated (VAI)
Jun 15, 2018
Drugs · Drug Quality Assurance
1 cited reference
21 CFR 211.68(b). Computer control of master formula records Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Voluntary Action Indicated (VAI)
Mar 6, 2015
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Warning Letters
Letters naming this establishment; each opens the letter
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard, warning letters and enforcement reports
Naucalpan, Mexico. Part of