1Labeling and packaging
There is a mismatched dosage form between the labeling and the listing SPL. 70146-005 Sports Balm, 1. Incorrect manufacturer included under the establishment section of listing SPL.
Inspection Record
Dr Sankunni’s Ayurvedic Research Foundation Private Ltd. — FDA Warning Letter Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Mismatched strength of menthol in the listing SPL. 70146-003 Womens Sports Balm 1. Incorrect manufacturer included under the establishment section of listing SPL.
3Labeling and packaging
The listing SPL does not include the active ingredient methyl salicylate which is found in the labeling.
4Other quality system
Mismatched strength of menthol in the listing SPL. 70146-004 Relief Balm 1. Incorrect manufacturer included under the establishment section of listing SPL.
5Labeling and packaging
There is a mismatched dosage form between the labeling and the listing SPL. 70146-006 Womens Relief Balm 1. Incorrect manufacturer included under the establishment section of listing SPL. 70146-007 Womens Sports Balm 1. Incorrect manufacturer included under the establishment section of listing SPL.
6Other quality system
Mismatched strength of menthol in the listing SPL. 70146-002 Sports Balm 1. Incorrect manufacturer included under the establishment section of listing SPL.
7Labeling and packaging
There is a mismatched dosage form between the labeling and the listing SPL. 70146-009 Sports Balm 1. Incorrect manufacturer included under the establishment section of listing SPL.
8Labeling and packaging
There is a mismatched dosage form between the labeling and the listing SPL. 70146-010 Womens Relief Balm 1. Incorrect manufacturer included under the establishment section of listing SPL.
9Labeling and packaging
There is a mismatched dosage form between the labeling and the listing SPL. 70146-011 Womens Sports Balm 1. Incorrect manufacturer included under the establishment section of listing SPL.
10Labeling and packaging
There is a mismatched dosage form between the labeling and the listing SPL. 70146-008 Relief Balm 1. Incorrect manufacturer included under the establishment section of listing SPL.
11Labeling and packaging
There is a mismatched dosage form between the labeling and the listing SPL. 70146-012 Hand Sanitizer 1. Incorrect manufacturer included under the establishment section of listing SPL. Therefore, your firm has not fulfilled its listing obligations under section 510(j) of the FD&C Act, 21 U.S.C. 360(j), which is a prohibited act under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). In addition, the drugs: Relief Balm, NDC 70146-000; Womens Relief Balm, NDC 70146-001; Sports…
12Labeling and packaging
Mismatched strength of menthol in the listing SPL. 3.The labeling also includes a carton label image of another product which is not listed. 70146-001 Womens Relief Balm 1. Incorrect manufacturer included under the establishment section of the listing SPL.
About this record
Extracted automatically from the document US FDA published on 2024-04-23. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
