5 ms·
The last paragraph from the FDA letter: "Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm.
by petee 5y ago
The last paragraph from the FDA letter:
"Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA."
If they skipped step one, I doubt they didn't skip more.
FDA letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/owlet-baby-care-inc-616354-10052021 https://www.fda.gov/inspections-compliance-enforcement-and-c...